Opal Medical Devices Summit 2017

Fairmont Scottsdale Princess, Scottsdale, AZ
January 9, 2017 - January 10, 2017

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In today's highly regulated environment, medical device and combinations product manufacturers cannot ignore even the smallest challenges at every stage of development--or during use in healthcare and clinical settings.

Fortunately, Opal Group's Medical Devices Summit is here to provide a platform for a bench-to-bedside discussions every medical device and combination product professional needs.

Please join us on January 9th - 10th, 2017, at the Fairmont Scottsdale Princess for a series of discussions on:

Early-Stage Development

Mid-to-Late-Stage Development

Product Launch

Lifecycle Management

Critical Quality Attributes

Human Factors

Cyber security

Telemedicine

Robotics

The Medical Devices Summit attracts professionals from Medical Device, Pharma, Biotech and Drug Delivery who will learn new strategies for concept development, navigating the regulatory landscape, and managing risk and maintaining quality throughout the product life cycle.

Current as of February 6, 2017

7:00am

Exhibit Setup

7:30am

Continental Breakfast and Registration

8:15am

Chairman’s Welcoming Remarks

8:30am

Best Practices for Compliance with the new ISO13485:2016

In the first half of 2016 we’ve moved form ISO 13485 :2003 to ISO 13485:2016. With the new standard in place, what are some of the most significant highlight? What steps should an organization take to facilitate a seamless transition during next 3 years?

Moderator

David Hankin, Chief Executive Officer, Alfred Mann Foundation for Scientific Research

Panelist

Angelica McParlane, Site Quality Manager, GE Healthcare

Panelist

Michael Zagorski, Director of Regulatory Affairs, ImPACT Applications, Inc.

9:30am

Requirements for a Strong Design Control Process (With a Software Twist)

Recognizing and mitigating software risk by implementing risk analysis of the systems at the early stage of design. What processes and policies can be implemented to prevent costly corrections?

Panelist

Walt Murray, Chief Executive Officer, ARC Experts Consulting Service

Panelist

Mary Ann Smith, Director, Regulatory Policy Digital Medicines and Devices, Novartis

Panelist

Eric Henry, Head of QA/QE, Phillips

10:30am

Morning Coffee Break

10:50am

Medical Device Innovation and Manufacturing

From a startup to a large organization, our expert panelists will discuss challenges of moving from early stage development to manufacturing, including strategic approaches to developing and protecting your intellectual property, overcoming technical and regulatory hurdles, and navigating through the intersection of innovation and law.

Moderator

Aaron Parker, Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Panelist

Justin Hendrix, Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Panelist

Philip Remedios, Principal, Director of Design & Development, BlackHägen Design, Inc.

Panelist

Asmita Khanolkar, Manager Manufacturing Engineering, CEQUR

12:00pm

Effective Supplier Management for the Medical Device Industry

How to choose and manage vendors with time, cost and quality in mind.
What are the complexities of establishing and maintaining procedures to ensure FDA’s Title 21 820 compliance. Are ISO standards enough? Should we involve the supplier in design process to establish quality requirements and improve retention?

Panelist

Joshua Simms, Branch Chief, U.S. Food and Drug Administration

Panelist

Shannon Rose Farrell, Senior VP Global Sales & Life Science Strategy, Argos Multilingual

Panelist

Tim Hasler, Senior Associate III, Corporate Quality Device Systems, Biogen

12:50pm

Networking Lunch

2:00pm

Dignity of Living
Everyone talks about the Dignity of a Dying, but few talk about the Dignity of Living. Seeing our family members’ and friends age, and helping them out along the way, constantly reminds us that the choices available to everyone for buying well-designed products dramatically decrease as one ages. Products we buy quickly migrate from being objects of desire to objects of necessity. Dr. Rutter shares his excitement, vision, experience and personal journey as a patient in researching and designing products that promote dignity. He illustrates the potency of his Synesthetic Design Strategy and how this thinking can be used to design products that fit perfectly, perform flawlessly and look beautiful allowing people to age with dignity.

Presenter

Dr. Bryce Rutter, Founder and CEO, Metaphase Design Group Inc.

2:30pm

Transforming UDI into ROI
Join UDI architect, Jay Crowley (USDM) along with panelists Marc Miller (TransPerfect Medical Device Solutions) and Charlie Kim (121nexus) to discuss the emerging “system of systems” approach to leverage UDI, mobile, and content automation technologies to eliminate mislabeled product and enable direct-to-user sales – while reducing labeling cost, risk, and turnaround

Panelist

Jay Crowley, VP and UDI Practice Lead, Former UDI lead at FDA

Panelist

Charlie Kim, President and CEO, 121nexus

Panelist

Marc Miller, Division President, TransPerfect Medical Device Solutions

3:20pm

Exploring the Challenges and Opportunities in Developing Pediatric Medical Devices

With Pediatric Device Consortia Grant Program in place the FDA has awarded 3.535 million dollars in 2015. Albeit awareness campaigns why don’t we see more of much needed development in this difficult to navigate space?

Presenter

Angel Adams, Chief Executive Officer, Catchwind Pediatric Innovations

Presenter

Donald Lombardi, Chief Executive Officer, Institute for Pediatric

4:00pm

Device Connectivity – Internet of Health
The benefits of going wireless are tremendous and when paired with the new wave of wearables these solutions will revolutionize care and treatment.
To successfully implement wireless technologies developers have to choose the right approaches-solutions and understand the options for wireless.
Successful implementation has to address the security concerns.

Moderator

Bill Saltzstein, President, Code Blue Communications

Panelist

Philip Remedios, Principal, Director of Design & Development, BlackHägen Design, Inc.

Panelist

Mary Ann Smith, Director, Regulatory Policy Digital Medicines and Devices, Novartis

5:30pm

Cocktail Reception

College Football Playoff National Championship Viewing

7:00am

Continental Breakfast and Registration

8:15am

Chairman’s Welcoming Remarks

8:30am

Cyber Security

FDA’s 2015 warning on remotely controlled infusion pumps and recent MedStar Health breach are a grim reminder of institutional vulnerability. How does the institutional vulnerability affect device security and the future of connectivity? Our esteemed experts will explore the security of connectivity.

Moderator

Eric Henry, Head of QA/QE, Phillips

Panelist

Marc Schneider, Principal Cyber Security Engineer, MITRE

Panelist

Axel Wirth, Distinguished System Engineer, Solutions Architect, Symantec

9:30am

Morning Coffee Break

9:50am

Full product Lifecycle Traceability: The Golden Key To Proof of Compliance

As medical devices grow more complex, demonstrating regulatory compliance requires advanced analysis of device design, manufacturing quality and risk management. Join us while a panel of industry experts discuss traceability best practices for compliance to ensure business and engineering alignment, information management and contextualized communication from start to finish.

Moderator

Edwin Lindsay, Director of Regulatory, Qspine

Panelist

Brad Milos, Principal Development QA Engineer, Minnetronix

Panelist

Tieming Ruan, Principal Engineer, Biogen

11:00am

Funding Early Stage

Funding for early stage development has been drying up in recent years. Who is currently funding and what are some of the innovative options

Moderator

James Rosebush, Founder and CEO, Growth Strategy

Panelist

Sergey Sirotinin, Chief Executive Officer, Dbaza Health

Panelist

Cameron Plummer, CEO, Innurvation

12:00pm

Networking Lunch

1:10pm

Protecting and Licensing Inventions Developed From Government Funded Research
Funding from U.S. Government sources like the NIH is vital to innovation of pharmaceuticals and medical devices. Funded research may complicate how rights to inventions made with the help of Uncle Sam can be used. The conflicting demands of research and the patent law can sometimes put scientific work at odds with effective patent protection. We will discuss issues faced by government agencies, academic institutions and potential industry partners that are considering licensing rights to inventions developed from government funded research. We will discuss how such funding affects the right to exploit and to license IP. We will look at what government agencies and academic institutions could do to effectively secure IP rights that not only serve the public good but that are also attractive to investors, therefore increasing the likelihood of commercialization success.

Panelist

Ami Gadhia, Technology Transfer and Patenting Specialist, NIH

Panelist

Stephen Lieb, Intellectual Property Attorney, Frommer Lawrence & Haug LLP

1:50pm

Human Factors Awareness:

Human factors validation testing covers a broad spectrum of devices.
What are good human factors practices in the design of medical devices.
Can human factor awareness lead to a more user friendly safer products?

Moderator

Ella Cozmi, Human Factors Engineering Consultant, Human Factoring Rx

Panelist

Edmond Israelski, Director of Human Factors, AbbVie

Panelist

Scott Bednar, Chief Executive Officer, QA/RA Consulting Group, Inc.

Panelist

Atul Mahajan, Sr. Manager, Engineering, Stryker

Panelist

Dr. Bryce Rutter, Founder and CEO, Metaphase Design Group Inc.

2:40pm

FDA Purchasing Controls and Supplier Management

Joshua Simms, Branch Chief, U.S. Food and Drug Administration

3:30pm

Combination Products Realm

One of the challenges of combination products is to create processes that will deal efficiently with the unknown. What are some of the solutions for dealing with the unknown? What are some of the compliance requirements in combination products when dealing with pharma?

Giridhar Thiagarajan, R&D Engineer, CR Bard

4:10pm

Closing Remarks

5star
Fairmont Scottsdale Princess
7575 E Princess Dr, Scottsdale, AZ 85255, United States


King Bed $309
Double/Double $309
Exclusive of one time $12 porterage fee (per person), $2 house keeping fee per room / per night and state and local taxes, currently 13.92%. Government Rooms are subject to approval.
  • Rooms are available only to those participants who are registered conference attendees.
  • Rooms will not be guaranteed without a credit card.
  • Rooms are allocated on a first come first serve basis. Room types/rates are subject to availability.
  • The name on the form will be the name of the guest room.

Registration Pricing

Standard Rate
Service Providers & Vendors $995
Government and Academic Faculty** $395
Employees of Medical Device Manufacturers (Including Startups) $395

Subject to approval. To qualify you must be currently employed by a non-vendor company. Eligibility will be verified by Opal Group. Opal Group reserves the right to allocate places and to refuse applications.

** Excluding contract manufacturers and other service providers

Sponsorship, Exhibition & Speaking Opportunities 212.532.9898 info@opalgroup.net
  • Stephen Smith, Medical Device Investigator, US Department of Health and Human Services
    Joshua Simms, Branch Chief, U.S. Food and Drug Administration
    Linda Chatwin, North American Manager Medical Device Regulatory Services, UL, LLC
    Eric Henry, Global Head of QA/QE, Philips Healthcare
    Phil Raymond, Director, Wireless Competency Center, Philips Healthcare
    Mary Ann Smith, Director, Regulatory Policy Digital Medicines and Devices, Novartis
    Nicholas Mourlas, Sr. Director New Ventures, Johnson & Johnson Innovation
    Axel Wirth, Distinguished System Engineer, Solutions Architect, Symantec
    David Hankin, CEO, Alfred Mann Foundation for Scientific Research
  • Angel Adams, Chief Executive Officer, Catchwind Pediatric Innovations
    Michael Zagorski, Director of Regulatory Affairs, ImPACT Applications, Inc.
    Chase Curtiss, Chief Executive Officer, Thelium
    Alan Pitt, Chief Medical Officer, Avizia
    Donald Lombardi, Chief Executive Officer, Institute for Pediatric Innovation
    Ella Cozmi, Human Factors Engineering Consultant, Human Factoring Rx
    Sergey Sirotinin, Chief Executive Officer, Dbaza Health
    Ami Gadhia, Technology Transfer and Patenting Specialist, NIH
    Walt Murray, Chief Executive Officer, ARC Experts Consulting Service
    Scott Bednar, Chief Executive Officer, QA/RA Consulting Group, Inc.
    John Thomas, Managing Director, Woodside Capital

In today’s highly regulated environment, medical device and combinations product manufacturers cannot ignore even the smallest challenges at every stage of development–or during use in healthcare and clinical settings. Fortunately, Opal Group’s Medical Devices Summit is here to provide a platform for a bench-to-bedside discussions every medical device and combination product professional needs.

The Medical Devices Summit attracts professionals from Medical Device, Pharma, Biotech and Drug Delivery who will learn new strategies for concept development, navigating the regulatory landscape, and managing risk and maintaining quality throughout the product life cycle.

Please join us on January 9th – 10th, 2017, at the Fairmont Scottsdale Princess for a series of discussions on:

Early-Stage Development
Mid-to-Late-Stage Development
Product Launch
Lifecycle Management
Critical Quality Attributes
Human Factors
Cyber security
Telemedicine
Robotics